ASTM International has released Standard F3067-14 “Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents”. This document provides guidance for developing in vitro test methods for measuring the radial strength or collapse pressure of balloon-expandable vascular stents and chronic outward force of self-expanding vascular stents.
In section 6.12 the standard references a “Segmented Head Apparatus” that can be used as a test method. MSI is proud that ASTM recognizes the test method we created in 2003 as an approved test method for the entire stent industry. Our model RX550 is shown in Figure 3.
The standard can be purchased for $50 at the ASTM website. https://www.astm.org/Standards/F3067.htm
It includes detailed instructions for radial strength testing of balloon-expandable stents and chronic outward load testing of self-expanding stents, as well as methods for calculating radial strength with radial loading curves or calculating min and max chronic outward force for self-expanding stents.
The appendices include basis for use of unloading line to evaluate radial strength of balloon-expandable stents and example of pulsatile excursion testing for self-expanding stents.